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Phase I Study of XTL6001 Injection in Healthy and Obese Subjects

NCT07205432 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-10-03

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) and multiple ascending dose (MAD) of XTL6001 injection in healthy and obese adult subjects.

SAD study: Includes 5 dose cohorts, with 40 subjects planned for enrollment. MAD study Includes 2 dose cohorts, with 30 subjects planned for enrollment.

Conditions

  • Weight Management in Adult Patients With Obesity or Overweight

Interventions

DRUG

XTL6001

XTL6001 is a triple-target Glucagon-like peptide-1 receptor （GLP-1R） relevant agonist, intending to manage overweight/obesity and other metabolic diseases

DRUG

Placebo

This intervention contains no active ingredients

Sponsors & Collaborators

  • Shanghai Xitaili Biomedicine Technology co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-13
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07205432 on ClinicalTrials.gov